In an effort to improve health surveillance and regulation in Honduras, the Health Regulatory Agency (ARSA) has announced the creation of three new specialized entities: the National Center for Technovigilance, the National Center for Pharmacovigilance, and the National Center for Foodborne Diseases.
These institutions will be responsible for enhancing the oversight of medical devices, pharmaceutical products, and food safety in the country.
Functions and responsibilities of the new entities
National Center for Technovigilance (CNTV)
The CNTV will be attached to the Medical Devices and Other Health-related Devices Directorate of ARSA and will focus on post-market surveillance of medical devices and other health products. Its main responsibilities include:
- Identifying and managing risks related to medical devices.
- Issuing health alerts in case of incidents or failures.
- Developing regulations to prevent and control risks.
- Coordinating with national and international entities in the field of technovigilance.
National Center for Pharmacovigilance (CNFV)
This center will be attached to the Pharmaceutical Products Directorate of ARSA and will oversee the safety, efficacy, and quality of medications in the country. Its key functions include:
- Monitoring and evaluating adverse drug reactions.
- Investigating events related to vaccination and immunization.
- Developing regulations and pharmacovigilance protocols.
- Providing training and education to healthcare professionals on medication safety.
National Center for Foodborne Diseases (CENETA)
Under the supervision of the Food and Beverages Directorate of ARSA, CENETA will play a key role in preventing and controlling outbreaks of foodborne diseases. Its main tasks include:
- Identifying and monitoring outbreaks of foodborne diseases.
- Implementing regulations and food safety standards.
- Coordinating with both the public and private sectors to ensure food safety surveillance.
- Training food handlers and healthcare professionals in good hygiene practices and quality control.
Impact and considerations for the regulated sector
The creation of these institutions marks a significant shift in health regulation in Honduras. Companies that manufacture, import, distribute, or market medical devices, pharmaceuticals, and food products will need to comply with the new guidelines established by these entities, including the mandatory reporting of adverse incidents and safety issues.
angel.irias@garciabodan.com
Associate
García & Bodán
Honduras